Observational studyIndian heart journal
Observational study to evaluate the safety and efficacy of saroglitazar in Indian diabetic dyslipidemia patients.
Observational study in Indian heart journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Efficacy and Safety of Saroglitazar in Patients with Cardiometabolic Diseases: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Clinical drug investigation · 2022Pooled it
- Pooled it
- Effect of a Dual PPAR α/γ agonist on Insulin Sensitivity in Patients of Type 2 Diabetes with Hypertriglyceridemia- Randomized double-blind placebo-controlled trial.Scientific reports · 2019Trial
- Article
- Review
- Article
- Novel Therapeutics for Type 2 Diabetes Mellitus-A Look at the Past Decade and a Glimpse into the Future.Biomedicines · 2024Review
- Dual PPRαϒ Agonists for the Management of Dyslipidemia: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.Journal of clinical medicine · 2023Review
- Unraveling the Potential Role ofInternational journal of molecular sciences · 2023Article
- Current and Emerging Approaches for Hepatic Fibrosis Treatment.Gastroenterology research and practice · 2021Review
- Saroglitazar in patients with non-alcoholic fatty liver disease and diabetic dyslipidemia: a prospective, observational, real world study.Scientific reports · 2020Observational
- Common Drug Pipelines for the Treatment of Diabetic Nephropathy and Hepatopathy: Can We Kill Two Birds with One Stone?International journal of molecular sciences · 2020Review
- New dual peroxisome proliferator activated receptor agonist-Saroglitazar in diabetic dyslipidemia and non-alcoholic fatty liver disease: integrated analysis of the real world evidence.Cardiovascular diabetology · 2019Review
- A Contemporary Overview of PPARα/γ Dual Agonists for the Management of Diabetic Dyslipidemia.Current molecular pharmacology · 2019Review
- Current and future pharmacological therapies for NAFLD/NASH.Journal of gastroenterology · 2018Review
- Biopharmaceutical Characterization and Bioavailability Study of a Tetrazole Analog of Clofibric Acid in Rat.Molecules (Basel, Switzerland) · 2017Article
- Peroxisome Proliferator-Activated Receptors and Their Agonists in Nonalcoholic Fatty Liver Disease.Journal of clinical and experimental hepatologyReview
- From 'Make in India' to 'Made in India': the saroglitazar story.Indian heart journalArticle
Corrections and comments
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Authors and funding
5 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledSaroglitazar is a dual PPAR α/γ agonist approved in India for the management of diabetic dyslipidemia.
aimsThe objective of this study was to evaluate the safety and efficacy of saroglitazar 4 mg once daily in clinical practice.
methodsThis was an observational, multicenter, single-arm study. Patients with type 2 diabetes (with on-going antidiabetic medication), age above 18 years, and triglycerides ≥200 mg/dL were included.
resultsA total 2804 patients with a mean duration of diabetes 6.29 yrs were included in this analysis. The baseline demographic profile was: mean age of 53 yrs, mean body weight 72.3 kg and mean BMI of 27 kg/m(2). 62.5% patients were male and 57.8% were reported to be on statin therapy at baseline. All 2804 patients were on antidiabetic medications with 15.4% patients on monotherapy and rest were on two or more than two antidiabetic medications at baseline. The baseline triglycerides and HbA1C values were 312.3 mg/dL and 8.3% respectively. At 3 months follow-up, use of saroglitazar 4 mg led to significant reduction in TG (35.8%), LDL-C (16.4%), total cholesterol (19%) and non-HDL-C (23.4%). Addition of saroglitazar to baseline antidiabetic medications showed a significant 0.9% absolute reduction in HbA1c with significant improvement in fasting and post prandial plasma glucose. No serious adverse events, alteration in liver or renal enzymes and edema or weight gain were reported.
conclusionSaroglitazar is a potential therapeutic option in type 2 diabetic patients with high TG levels, not controlled by statins, for comprehensive control of lipid and glycemic parameters with acceptable safety profile.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.